Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use
PYO · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.5240
Classification
FDA Product Code
PYO
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 880.5240
Review panel
SU
Medical specialty
General Hospital
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin